ICU Medical B9650Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709014763), received between Oct 11, 2023 and Dec 12, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

187 other recalls cover devices cleared under the same FDA submission (K964435); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 12, 2026Class IIOpen, Classified

   Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

   Z-3163-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE PRODUCT INVOLVED IS A 102" (259 CM) APPX 15.4 ML, 10 DROP ADMIN SET W/0.2 MICRON FILTER, CLAVE¿, ROTATING LUER, AND THE EVENT DATE IS UNKNOWN. AS PER THE REPORT, THERE WAS A LEAK AT THE CATHETER HOOK UP. THERE WAS NO HOLE, CUT OR TEAR OR ANY DEFECT THAT THE CUSTOMER COULD SEE. THE INCIDENT HAPPENED AFTER CONNECTING THE PATIENT AND STARTING THE IV LINE. THE CUSTOMER DISCONNECTED THE PATIENT AND STARTED A NEW LINE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312440 ↗
• MalfunctionOct 11, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 102" (259 CM) APPX 15.4 ML, 10 DROP ADMIN SET W/0.2 MICRON FILTER, CLAVE®, ROTATING LUER WHERE IT WAS REPORTED ONE OF THE INTRAVENOUS (IV) ADMIN SETS HAD A CRACKED INLET AND WAS RELEASING BLOOD ONTO THE PATIENT'S ARM. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17917169 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0256-2021 · Jul 6, 2020 · Terminated
  149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;
• Z-0210-2021 · Jul 6, 2020 · Terminated
  13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)108
• Z-0207-2021 · Jul 6, 2020 · Terminated
  13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)
• Z-0209-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709090238(17)250101(30)50(10)45729
• Z-0226-2021 · Jul 6, 2020 · Terminated
  112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088518(17)241101(30)25(10)4475764 (01)108
• Z-0259-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)1
• Z-0243-2021 · Jul 6, 2020 · Terminated
  78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)10887709121703(17)250201(30)50(10)4723226.
• Z-0254-2021 · Jul 6, 2020 · Terminated
  22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10

…and 172 more.